It is often desirable to hold, maneuver, and retain tissue during medical procedures. Devices for gripping, holding, and manipulating tissue are thus often very useful during medical procedures, particularly ones involving tissues, organs, and structures that are relatively inaccessible or otherwise difficult to reach or to retain.
In many medical procedures, it is useful to locate the cervix and cervical os of a female patient. For example, location of the cervical os and cervix is necessary for proper positioning for the performance of a dilatation and curettage procedure. In order to perform a hysterectomy, particularly with a transvaginal approach, it is often useful to grasp the cervix. This may aid in orienting the uterus, in reducing unwanted motion of the uterus during a procedure, or to manipulate the uterus into a favorable position during treatment. Devices and methods for grasping, retaining and manipulating a uterus may be useful in many other medical procedures as well.
A hysterectomy (surgical removal of the uterus) is performed on approximately 800,000 women annually in the United States and is often the therapeutic choice for the treatment of uterine cancer, adenomyosis, menorrhagia, uterine prolapse, dysfunctional uterine bleeding (abnormal menstrual bleeding that has no discrete anatomic explanation such as a tumor or growth), and muscular tumors of the uterus, known as leimyoma or uterine fibroids.
However, hysterectomy is a drastic treatment, entailing the removal of the uterus and the resulting loss of reproductive function. Thus, any method which can approximate the therapeutic result of a hysterectomy without removing the uterus would be a significant improvement in this field. Newer treatment methods have been developed for some diseases which may spare these women a hysterectomy.
In 1995, it was demonstrated that uterine fibroids could be treated without hysterectomy using a non-surgical therapy, specifically comprising bilateral intraluminal occlusion of the uterine arteries (Ravina et al., “Arterial Embolization to Treat Uterine Myomata”, Lancet Sep. 9, 1995; Vol. 344; pp. 671-692, incorporated in its entirety herein). This technique is known as “uterine artery embolization”. In this technique, uterine arteries are accessed via a transvascular route from a common femoral artery into the left and right uterine arteries and embolic coils are deposited in the uterine arteries to occlude the arterial passageways
The uterus has a dual (or redundant) blood supply, the primary blood supply being from the bilateral uterine arteries, and the secondary blood supply from the bilateral ovarian arteries. Consequently, when both uterine arteries are occluded, i.e. bilateral vessel occlusion, the uterus and the fibroids contained within the uterus are both deprived of their blood supply. However, as demonstrated by Ravina et al., the effect on the fibroid is greater than the effect on the uterus. In most instances, the fibroid withers and ceases to cause clinical symptoms. See also Burbank, et al., “Uterine Artery Occlusion by Embolization or Surgery for the Treatment of Fibroids: A Unifying Hypothesis-Transient Uterine Ischemia,” The Journal of the American Association of Gynecologic Laparoscopists, November 2000, Vol. 7, No. 4 Supplement, pp. S3-S49. U.S. Pat. No. 6,254,801, to Burbank et al., entitled “Methods for Occlusion of the Uterine Arteries,” describes numerous devices and methods useful for occluding a uterine artery by penetrating the tissue of the patient to access the uterine artery, which is incorporated herein in its entirety by reference.
However, catheter-based uterine artery embolization under radiologic direction requires specialized equipment and sophisticated procedures. Accordingly, far fewer uterine artery embolizations than hysterectomies are performed for uterine fibroids which are symptomatic.
What is needed, therefore, are devices and methods to locate, retain and manipulate the cervix, uterus and related tissues and near-by anatomical structures that can be used by physicians in a simple clinical setting or environment to aid in therapeutic procedures.